FDA issues CRL to small Dutch biotech's breast cancer ADC as OS figures fail to impress
The FDA has batted back an application for a potential breast cancer therapy.
US regulators issued a complete response letter to the small Dutch biotech Byondis, rejecting its pitch for an antibody-drug conjugate combining Herceptin with the company’s experimental drug duocarmazine. Byondis did not say what prompted the CRL, noting only in a press release that the FDA wanted more information requiring “time and resources that extend beyond the current evaluation period.”
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